Introduction

In a rapidly evolving healthcare landscape, the intersection of research and policy has emerged as a critical focal point for ensuring patient access, affordability, and fostering innovation. Bridget Doherty, Director of the Access and Policy Research team at Johnson & Johnson, emphasizes the pivotal role of evidence-based policymaking in transforming healthcare delivery and patient outcomes.

Johnson & Johnson’s Strategic Commitment

Johnson & Johnson has recognized the necessity of integrating research and evidence into healthcare policy, leading to the formation of a dedicated team focused on this mission. "A position without evidence is just an opinion," Doherty asserts, underscoring the importance of substantiating policy positions with rigorous research. The team’s objective is to harness multidisciplinary research to inform policy that ultimately benefits patients and the healthcare system.

The Four Pillars of Policy Research

The Access and Policy Research team operates under a strategic framework centered around four key pillars: value assessment, insurance design, the value of innovation, and ecosystem policy research. Each pillar addresses a crucial aspect of healthcare policy:

1) Value Assessment: The team ensures that policy decisions reflect the comprehensive value that medicines bring to patients and society. By conducting thorough research, they aim to influence policy decisions that acknowledge the true worth of healthcare innovations.

2) Insurance Design: Research in this area focuses on creating insurance models that prioritize patient access and affordability. Doherty’s team examines existing designs and proposes reforms to enhance patient care accessibility.

3) Value of Innovation: This pillar quantifies the societal benefits of pharmaceutical innovations, advocating for policies that support and encourage ongoing research and development. "We quantify what our industry brings to the system," Doherty explains, highlighting the need for policies that recognize and sustain the value of innovation.

4) Ecosystem Policy Research: In a dynamic policy environment, understanding the impacts of legislative and regulatory changes is vital. The team studies these changes to assess their effects on patients and the broader healthcare ecosystem.

Case Study: The FDA's Accelerated Approval Program

A compelling example of the team’s work is their research on the FDA's accelerated approval program, which allows earlier access to promising medications for patients with significant unmet needs. Facing critiques of the program, the team conducted a comprehensive study to evaluate its impact on patient outcomes. Their findings, published in the Journal of the National Comprehensive Cancer Network, revealed that from 2006 to 2022, the program added an estimated 263,000 life years for oncology patients, demonstrating its vital role in patient care.

Engagement and Advocacy

Doherty stresses that publication is merely the beginning of the engagement process. The team actively collaborates with internal and external stakeholders to disseminate their research, ensuring it reaches policymakers, healthcare providers, and advocacy groups. By engaging with these audiences, the team aims to influence policy discussions and foster an evidence-based policymaking ecosystem.

Continued Impact and Future Directions

The Access and Policy Research team’s efforts have already influenced policy conversations, gaining recognition from organizations like the FDA and the National Pharmaceutical Council. As policy challenges intensify, Doherty envisions the team expanding to enhance their impact further. "Good policy is built on evidence, which can help patients," she concludes, urging industry professionals to adopt a similar evidence-driven approach to policy development.

Key Takeaways:

1) Evidence is Essential: "A position without evidence is just an opinion," emphasizing the need for data-driven policy decisions.

2) Four Strategic Pillars: Value assessment, insurance design, value of innovation, and ecosystem policy research guide the team’s work.

3) Significant Impact: The FDA's accelerated approval program research demonstrated the program’s contribution of 263,000 life years, underscoring its importance.

4) Publication as Engagement: Disseminating research is crucial for influencing policy; collaboration with stakeholders amplifies the impact.

5) Future Growth: As policy challenges grow, expanding the research team is crucial to maintaining and enhancing their influence on healthcare policy.

By integrating rigorous research into policy development, Johnson & Johnson’s Access and Policy Research team is paving the way for a more informed and patient-centric healthcare system.

"We're all in the healthcare space, we're all aiming to improve patient outcomes. So we think we understand each other, but in the same way tennis players and ice hockey players play sports, if you go onto the ice with a tennis racket, you're going to end up in serious trouble,"

he explains.

These differences manifest in various ways, from decision-making timelines to expectations around regulatory approval. While pharma companies view regulatory approval as "business go," startups often see it as just the beginning of their journey.

Cassidy advocates for "agile co-creation" as the solution: "It's about making sure that when you're working with a partner, you understand why your partner is wanting to work with you, what is the benefit for their business and their objectives."

Scaling Digital Health Solutions in Emerging Markets

Nipun Jain, Head of Innovation Hubs and Partnerships for International at AstraZeneca, approaches partnerships from a health equity perspective.

"Healthcare systems in lower-middle income group countries are under-resourced, over-leveraged, and patient outcomes are unfortunately not optimal," he notes.

AstraZeneca's approach involves identifying population health gaps in therapy areas where they have subject matter expertise, then partnering with startups to develop technological solutions. "Digital health is the great equalizer," Jain explains, describing how technologies like AI diagnostics and telemedicine can help healthcare systems in developing countries catch up to those in the developed world.

This strategy has yielded impressive results: "We have launched 17 health innovation hubs in countries across Latin America, Africa, Middle East, and Asia. We have created more than 200 partnerships, more than 100 with startups, more than 40 with government organizations. We have launched digital health solutions in more than 8,000 hospitals and we have impacted more than 11 million people so far."

The Power of Consortia in Driving Innovation

Adrian Gheorghiu, who leads Gravitate Health while also serving as a digital client partner at Pfizer, highlights how large consortia can effectively drive innovation. Gravitate Health brings together 45 members, including academia, pharma companies, and regulators, all aligned toward improving health outcomes by providing patients with relevant, trustworthy information.

"If you align all these members to a single and shared goal, then you start looking at how you make it work," Gheorghiu explains.

"A partnership of 45 members might seem too large, but I've noticed emerging partnerships across sectors that quickly address issues that previously would take longer."

The Venture Capital Perspective

Haider Alleg, General Partner at Allegory Capital, brings a venture capital perspective to the discussion. He emphasizes that the biotech investment model cannot simply be applied to digital health: "We tend to copy in digital health the biotech model, like 'let's build something that Novartis wants and Novartis will buy it.' And that doesn't happen."

Alleg sees tremendous potential in digital health, which he describes as "the last frontier of regulated industry where anything that we put at it is amazing." However, he notes that startups often struggle to scale due to the high cost of patient acquisition, suggesting that pharma companies could play a more significant role in helping these companies reach millions of patients.

Building Partnerships That Last

The panelists agree that successful partnerships require clear alignment on objectives from the outset. As Richard Cassidy advises:

"Look at all those partnerships you have, and if you can't link them back to your business goal and your partner's business goal, stop doing them."

For Nipun Jain, the key challenge is "aligning what is in it for everyone" and ensuring that startups understand that pharma companies are not the ultimate customers for their digital health solutions.

Adrian Gheorghiu emphasizes the importance of governance and shared goals in sustaining large consortia, while Haider Alleg calls for better connection between corporate venture capital in pharma and commercial objectives.

Key Takeaways:

1) "The science is embedded in the industry. The more there will be VCs coming up pouring investors' money and de-risking your initiatives, the more we are going to impact patients." - Haider Alleg

2) "If you can't link partnerships back to your business goal and your partner's business goal, stop doing them." - Richard Cassidy

3) "Digital health is the great equalizer where technologies can provide that edge to healthcare systems to cover the gap." - Nipun Jain

4) "Stay truthful to health impact. The collaborations can grow around that, and whatever side effects like making money or building reputation will come as well." - Adrian Gheorghiu

5) "Partnership is driven by looking at market forces and dynamics and being more proactive, absorbing risk in a different way compared to how big pharma operated in the past." - Adrian Gheorghiu

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